The purpose of this FOA is to call for applications to
develop an H3Africa Bioinformatics Network by implementing innovative,
cost-effective approaches to improving the connectivity among, and overall
bioinformatics infrastructure in, all of the components of the H3Africa
Consortium, including the H3Africa Collaborative Centers, research projects,
and biorepository(ies); to
fostering connectivity, interaction and coordination among African research
groups working in genomics-based research on human disease and health across
the continent; to promoting
pan-H3Africa communication; to
providing bioinformatics training of several types; to providing
services and support to build bioinformatics capacity at African research
institutions; to promoting
computational skills among African researchers; and to developing new
computational tools for genomics research in the African setting.

Key Dates

Posted Date

August 23, 2011

Letter of Intent Due Date

November 2, 2011

Application Due Date(s)

December 2, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January-March, 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

December 3, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide for Grants and Contracts). Conformance
to all requirements (both in the Application Guide and the FOA) is
required and strictly enforced. While some links are provided, applicants must
read and follow all application instructions in the Application Guide as well
as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

Purpose/Research
Objectives. Low- and middle-income nations suffer over ninety
percent of the world’s burden of premature mortality, as measured in lost years
of life. These countries, constituting three-quarters of the world’s population,
now must deal with a triple burden: the persistent cluster of infectious
diseases, malnutrition, and a growing incidence of chronic disease and
disabilities due to increased life spans and new risk exposures. The NIH has a
long-standing commitment to address both communicable and non-communicable diseases
around the world through health research and training, and one of NIH’s stated
priorities is enhancing efforts in global health. Genomics and other
large-scale biological studies provide cutting-edge approaches to research on
the genetic and environmental contributors to health and disease, the
understanding of which will lead to unimagined advances in medical science and
powerful new ways for improving human health. To maximize the impact on the
health of people globally, advances in the fields of
genetics/genomics/environmental studies must be integrated into the research
conducted in developing countries, as well as into their medical education and
health services. Notably, however, African researchers and populations are
substantially underrepresented in genomics and environmental research
endeavors. For example, it has been found, as documented in a recent
review, that, worldwide, the majority of the thousands of genetic studies
completed to date (about 75%) were conducted exclusively in populations of
European descent and only a fraction of the studies done with non-European
populations came from Africa (Rosenberg NA, Huang L, et al. (2010). Nat Rev
Genet 11(5):356-366). The paradox of limited genomics research conducted in
Africa and the centrality of contemporary African populations for our
understanding of human evolution and population genetics has been widely noted.

While there are pockets of research excellence in genetics
and environmental studies on the African continent done by African and other
scientists, a limited number of individuals have the expertise to engage in
this work compared to the overall population size and burden of disease there.
It is the objective of the H3Africa Initiative to enhance the capability of
African scientists and research institutions to use genomics and other powerful
new approaches to address problems of African health and disease. Increasing
African research capacity by building infrastructure, expanding the genomic
proficiency of researchers, and increasing the number of well-trained
individuals are essential to promote sustainable efforts to address the
challenges to advancing health and combating disease in Africa. While focused
on benefitting the people of Africa, such research may also be relevant
to the health of individuals in the U.S. and other countries worldwide,
particularly those of African descent. For example, many scientists believe
that different environmental exposures for a population whose genetic
architecture evolved in environments with a scarcity of available resources may
be an underlying contributor to disease in the U.S.

H3Africa is a partnership among the National Institutes of
Health (NIH, USA), the Wellcome Trust (WT, UK), and the African Society of
Human Genetics (AfSHG). A set of recommendations for H3Africa was developed by
a pair of working groups, composed primarily of African scientific experts, who
addressed the major scientific, ethical and practical issues in the development
of a large-scale genomics research program in Africa. The working groups
formulated a detailed proposal (which can be found in a white paper at www.h3africa.org) to address the goal of
creating and sustaining a network of African Centers that could carry out
training and research based on state-of-the-art genomics approaches. Through
support for infrastructure development, training, and specific research projects,
the working group recommendations were designed to catalyze genomics and
environmental research concerning human diversity, health, and disease biology
of particular relevance and benefit to African populations and societies. The
proposal was discussed at a public meeting held in Cape Town, South Africa in
March 2011 and the attendees ratified the white paper’s recommendations.

The research program described in this FOA is a response to
the disparities in research capacity noted above and is based, in significant
part, on the recommendations of the H3Africa white paper and from discussions
at the Cape Town meeting. The H3Africa Initiative aims to contribute to the
establishment of a viable, productive, and eventually sustainable, African
research infrastructure to study the genetic and environmental contributors to
disease and health. It aims to do so through a combination of the leveraging
of existing capacity, expertise and infrastructure with investment in new
research, infrastructure-building and training efforts.

H3Africa has three specific interrelated, interdependent
objectives. The first is to increase the human resources for conducting
cutting-edge genomics-based research in Africa through training, career
development and enhanced collaborations within Africa and with the African
scientific diaspora. The second is to support cutting-edge research that will
not only generate important findings and discoveries, but will serve as a
vehicle both for research training and for the improvement of the African
laboratories where the research is carried out. The third is to support the
improvement of specific types of infrastructure, i.e., biorepository capacity
and bioinformatics, which are needed to do genomics-based research. To achieve
these objectives, the H3Africa program at NIH will comprise several
components. Infrastructure improvement will be addressed by support for an
H3Africa Bioinformatics Network (this FOA) and for biorepositories in Africa
(see NOT-RM-11-015).
It is anticipated that one or more full-scale H3Africa Biorepositories will be
established in Africa. Research activities will be supported through both
Collaborative Centers (see companion FOA, RFA-RM-11-008U54)
and individual research projects (see companion FOA, RFA-RM-11-009U01;
also see a similar call for proposals from the Wellcome Trust at http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm).
Finally, there will be a small grant program that will be funded in FY13, to
support research on the societal implications of genomics in Africa. All
awards under the NIH H3Africa program will be made to African Institutions and
the majority of the awarded funds must be spent in Africa. All awardees will
participate in the H3Africa Consortium to further enhance the collaborative
nature of this Initiative.

H3Africa is funded, in part,
through the NIH Common Fund, which supports cross-cutting programs that are
expected to have exceptionally high impact. All Common Fund initiatives invite
investigators to develop bold, innovative, and often risky approaches to
address problems that may seem intractable or to seize new opportunities that
offer the potential for rapid progress. Updates on all NIH Common Fund
Global Health initiatives can be found at http://commonfund.nih.gov/globalhealth/grants.aspx.
The H3Africa website (http://h3africa.org )
will also have ongoing updates on H3Africa activities and information about
upcoming H3Africa meetings.

The current FOA calls for applications for a cooperative
agreement to support the H3Africa Bioinformatics Network.

Research
Objectives. As the capacity for using genomics-based
approaches for biomedical research in Africa grows, a similar increase is required
in the bioinformatics efforts to handle, store and analyze the genomic and
other relevant data that will be generated. Interest in bioinformatics is
gaining momentum in Africa, and there are now several research-specific,
country-based, or regional bioinformatics networks in place on the continent.
A network-based approach is highly relevant to the African context, and thus
the H3Africa Initiative will include an H3Africa Bioinformatics Network as a
key component that will incorporate some of the existing infrastructure.

Within H3Africa, bioinformatics activities are envisioned to
take place at several levels, with different purposes. Each of the individual
projects within the Collaborative Centers (U54s) and each of the individual
cooperative agreement research projects (U01s) will have to provide the
bioinformatics capability it needs for data generation, storage, submission to
public data resources, and for initial analysis. The Collaborative Centers
(U54s) will also need to be connected with one another to meet the integrated
bioinformatics needs of the larger research projects that they will be
undertaking. At a higher level yet, the H3Africa Bioinformatics Network is
being established to provide connectivity among all of the H3Africa research
sites (including those funded by the Wellcome Trust), to provide the training
in bioinformatics that is critically needed in Africa, and to conduct
bioinformatics research, particularly research that will lead to the
development of new computational tools customized to address the specific
issues of genomic research in African populations. Planning discussions to
date have imagined that the H3Africa Bioinformatics Network will be organized
as a central administrative site and associated bioinformatics nodes, or as a
“hub and spokes” model. However, applicants are free to propose any type of
organization that they wish that will meet the scientific objectives described
in this FOA.

Scientific
scope. The purpose of this FOA is to solicit applications to
establish an H3Africa Bioinformatics Network that will serve the H3Africa
Research Network’s research and training needs. The objectives of the H3Africa
Bioinformatics Network are to:

Provide a foundation to establish a high level of bioinformatics
capability across all parts of Africa;

Foster connectivity and interactivity among the H3Africa research
groups to enhance translational research
and bioinformatics across the continent, including support for collaborations,
by establishing the necessary links at the level of research groups and, as
possible, research institutions; by promoting cross-network communication
through, for example, teleconferences, webinars, virtual courses, social media,
distributed coding projects, and an on-line helpdesk; and by providing services
and support to build continental and local bioinformatics capacity;

Training at all levels for research scientists,
bioinformaticians, and computational support staff participating in H3Africa;

Providing opportunities for career and leadership development for
bioinformatics researchers;

Establishing multiple approaches to training in bioinformatics,
including on-site, in-person training and both synchronous and asynchronous
on-line education, including providing supporting infrastructure;

Supporting the development of skills needed to develop and
maintain bioinformatics infrastructure, including identifying the needs,
challenges, and solutions related to both equipment and the Internet;

Develop the skills and orientation to create or take advantage of
forward-looking solutions to the emerging obstacles posed by the large amounts
of data now being generated in genomics-based research, for example but not
limited to, the use of cloud computing for storage, analysis, and data transfer;

Facilitate and consult on data submission by H3Africa research
sites to international repositories, as well as access to data; provide
guidance for data management and storage, and data sharing;

Engage in bioinformatics research and development of
computational tools optimized for use in genomics-based research in Africa.

Overall
Vision. The application must provide an overall vision for the
H3Africa Bioinformatics Network, including how it will achieve the objectives
listed above, why the proposed organizational model was chosen, how that model
is optimal to achieve the goals of the H3Africa Initiative, and what is
innovative about the model in the African context.

The
Network. The H3Africa Bioinformatics Network will be expected
to work with the H3Africa research projects that are funded by both the NIH and
the Wellcome Trust, as well as with the biorepository projects. As a
guideline, the companion FOAs state that the NIH will fund up to three Collaborative
Centers, up to four research projects, and biorepositories. In addition, the
Wellcome Trust intends to make two to four awards, and these projects will be
included in the H3Africa Consortium (see http://www.wellcome.ac.uk/Funding/Biomedical-science/Funding-schemes/Strategic-awards-and-initiatives/wtvm052057.htm
). The funding agencies anticipate that the H3Africa Consortium may be
expanded as other funders contribute, so the application should discuss how
provision will be made for the addition of participants in the H3Africa
Research Network.

It is anticipated that there will be two types of sites with
which the H3Africa Bioinformatics Network will be involved:

Research sites: One of the remits of the Network is to link the
research sites participating in H3Africa. As noted above, the H3Africa
research projects themselves are expected to have or to build the local bioinformatics,
computational, and analysis capabilities needed for the conduct of the research
they propose; the H3Africa Bioinformatics Network is not responsible for
building such infrastructure and foundation for them. However, the Network
should play a consultative role, by providing advice to the research projects and
trainees on identifying and meeting their remaining needs, as well as keeping
them abreast of new analysis tools and other innovations that will help them to
build upon what is being supported by their own research funding.

The application should describe how the
Network will interact with the initially funded research sites and what
services and benefits will be offered to them. The application should also
discuss what capacity in terms of research sites it could handle beyond the
initial H3Africa sites, as well as any plans it may have for encouraging growth
by adding new Network participants. A fee-for-membership model may be
considered for non-H3Africa research sites, if needed, but the objective should
be to encourage membership.

Bioinformatics sites: While a site in the H3Africa
Bioinformatics Network may be at the same institution as one of the research
sites that will be competitively selected, it is recognized that there are also
existing sites in Africa that have strong bioinformatics capabilities and track
records, significant bioinformatics skills and infrastructure, but which may
not have all of the genomics-based research capability to be competitively
selected as a research project. Yet other sites may not be as well-developed
but are interested in building up their existing bioinformatics capabilities
and infrastructure. Applicants for the H3Africa Bioinformatics Network are
encouraged to consider including either or both of these types of sites in
their proposed Network, to the extent that doing so will facilitate meeting the
objectives of the H3Africa Initiative.

The application should provide information about all of the
proposed participating bioinformatics sites, including their existing
infrastructure, skills and needs; the role(s) that they will play in outreach
to the expanding African genomics community; and how the sites will contribute
to the synergy of the Network. The application should also specifically discuss
the following:

Training
and Career Building. As discussed above, one of the most
important remits of the H3Africa Bioinformatics Network is training. The
application should describe in detail an innovative and forward-thinking
training program, which may take place at both the Network research sites and
the Network bioinformatics sites. The application should discuss the
applicant’s vision for bioinformatics training in Africa and his/her experience
in bioinformatics training; how the training opportunities will be made widely
available to H3Africa sites across the continent; how the trainees will be
identified: whether and how additional training will be provided to the staff
of the Network’s training sites themselves; how the training provided will be
promulgated to benefit others who may not be direct members of the Network; and
how the Network’s several training activities will be coordinated.

Data
repositories. H3Africa research projects will be instructed to
submit their data to international databases, such as those at NCBI, EBI and
DDBJ. Therefore it is not anticipated that the H3Africa Bioinformatics Network
will have a need to establish a large database to archive sequence or other
molecular data, or phenotypic data. Rather than proposing to create new
archives, the application should discuss plans for how the Network will work
with users to help them to better be able to deposit to, and access data from, the
international databases.

Bioinformatics
research. The H3Africa Bioinformatics Network application may
include a bioinformatics research component. Examples of the types of research
that would be appropriate include the development of software or algorithms for
data processing, data mining, genomic data visualization, analysis, or other
bioinformatics and computational research tools useful for genomics research,
particularly the unique aspects of genomics research in Africa. While database
resources may in some cases be necessary as part of the Network, the major
focus of a research component is intended to be in the areas of data
processing, analysis, and interpretation for biological discovery, not in
database construction or services. The research component should be a
minority of the H3Africa Bioinformatics Network activities. As a guide, it would
be reasonable to consider devoting up to 10% of the requested funds to such
research, although a larger percentage of the budget may be requested with
appropriate justification.

Other
Network activities. There are many other activities that could
be provided by an H3Africa Bioinformatics Network to benefit the expanding
African genomics-based and bioinformatics research communities. Applicants are
encouraged to describe creative plans, in addition to what is called for above,
for using up-to-date tools and strategies to provide a robust and
state-of-the-art approach to the use of bioinformatics and computation for providing
maximum progress toward achieving the goals of H3Africa.

Several additional topics should be addressed in the
application:

Sustainability.
One of the major goals of the H3Africa program is to enable
African scientists to demonstrate their world-class skills through the
establishment of cutting-edge research programs that will lead to more
publications and other evidence of productivity, thereby increasing their
opportunities for future funding through competitive grant processes, as well
as through increased investment in research by national governments and private
sources. Applicants should discuss the issue of future sustainability
of bioinformatics infrastructure and capacity on the continent beyond the
H3Africa program and how the specific H3Bioinformatics Network will, during its
lifetime, contribute to the on-going future of cutting-edge research efforts in
Africa. This section of the application should be compatible with the letters
of Institutional and National commitments (see below) to provide an overview of
the long-term prospects for sustained bioinformatics structure, capacity and
research.

Data
Sharing and Release plan. A plan for data and resource sharing
and release is expected for all NIH applications (http://grants.nih.gov/grants/policy/data_sharing/).
Applicants are expected to provide a well thought-out plan for widely sharing
data, tools and other resources generated by the Bioinformatics Network to
further the H3Africa goal of encouraging more genomics-based research on health
and disease by African scientists. An application must have an acceptable Data
and Resource Sharing and Release plan before it can be funded, consistent with
the goals of the H3Africa initiative. After the awards have been made, the
H3Africa Consortium (see below) will develop a unified plan for data and
resource release, and the application must include a statement that the
investigators in the Bioinformatics Network will abide by the Consortium's data
and resource policy. Examples of current data release guidelines for NIH
programs can be found at: http://www.h3africa.org/dataReleasePolicy.cfm

H3Africa
Research Network Meetings: The NIH and the Wellcome Trust plan
to hold two H3Africa Consortium meetings per year, and applicants should
request funds to travel to these meetings in their applications. Most of the
meetings will be held in Africa. However, in the first year, one of the
Research Network meetings will be held in London, U.K., and in year three, one
will be held in Bethesda, MD in the U.S. For the meetings in Africa, travel
for up to 2 people from the grantee institution and up to a total of 6 from the
other bioinformatics sites combined will be allowed. For the meetings in
London and Bethesda, travel for the PD/PI and up to two will be allowed. Adequate
travel funds for these meetings must be requested in the application.
Additional people will be allowed to participate in the meetings if funding for
travel can be obtained from other sources.

Monitoring
and Evaluation Plan: The application must contain a plan for
how the project's progress, as well as funds and supported activities, will be
monitored and evaluated. The plan should discuss how the Bioinformatics Network
project will be assessed and how the applicant will define, identify, and
determine impact. The plan should also discuss how any necessary modifications
indicated as a result of the assessments will be effected. To facilitate the
monitoring and evaluation, the application should include a well-defined set of
yearly milestones for the research and training activities proposed. The
milestones will be negotiated and finalized at the time of award. The
milestones will be reconsidered on an annual basis to account for the Center’s
experience and progress, but will be subject to change only with the NIH
Program Director’s agreement. An example of the level of detail and
specificity needed for the milestones can be found in an example set of
acceptable milestones from past genomics projects, posted at http://www.h3africa.org/genomicsProjectMilestones.cfm.

Institutional
Commitment: The application should include a letter from an appropriate
institutional official (University or Medical School President, Dean or
Director, or the head research administrator or equivalent) from each of the
participating institutions, which substantiates the institution’s commitment to
the proposed project. Appropriate institutional commitment to the program
includes the provision of adequate staff, facilities, positions and resources
that can contribute to the planned program. The institution should state its
commitment to overcoming any administrative obstacles to the implementation of
the application, such as accommodation for participation by multiple Schools at
the university or collaboration with other institutions within or outside of
the applicant’s country. The letter should also briefly discuss the
institution's plans for sustaining an active program of scientific research.

As the programmatic activities of this initiative will
support national and international collaborations, letters of support from the
related national ministries such as the Ministry of Science, Ministry of Health
and/or Ministry of Education for each African country with a programmatic
component will be required. The letter should briefly describe the national
policy concerning the development of a national scientific research program and
how the country is addressing the target that the African Union set in 2006 for
each nation to spend 1% of its gross domestic product (GDP) on research and
development (R&D). It is highly recommended that these letters of support
be included with the application. If these are submitted later, this
could impact and delay the review of the application. An award will not be made
without receipt of these letters of support.

Section II. Award Information

Funding Instrument

Cooperative Agreement

Application Types Allowed

New
The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The total amount of funds available for the
Bioinformatics Network is approximately $3.1M total cost for FY2012 and $2.2M
total cost per year for FY13-16, contingent upon receiving scientifically
meritorious applications. One award is anticipated from this solicitation.

Award Budget

As only one award will be made, the total cost of the
budget may not exceed the total costs given above.

Award Project Period

The maximum period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

The PD/PI should be an established leader in the academic
and scientific area in which the application is targeted, and be capable of
providing administrative, clinical, and scientific leadership to the
development and implementation of the proposed program.

More than one PD/PI (i.e., multiple PDs/PIs), may be
designated on the application for projects that require a “team science”
approach and therefore clearly do not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.
All PDs/PIs must be registered in the NIH electronic Research Administration
(eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm
for instructions).

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application Guide
and the Table
of Page Limits must be followed, with the following exceptions or
additional requirements:

Research Plan section is limited to 30 pages.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

The sections listed below are all part of the 30 pages of
the Research Strategy.

Overview.
The narrative portion of the application should begin with an overview that
addresses the following: the rationale and vision for the proposed H3Africa
Bioinformatics Network, a brief description of the network to be developed,
community support for the proposed network, and the anticipated overall impact
of the network on genomics research in Africa. The overview should also
include a summary description of the project's components. The
overview should include preliminary data that support the technological
approach planned to establish the network, if appropriate. The vision for the
long-term sustainability of the H3Africa bioinformatics network must be
discussed.

Project
Description. Development of the Bioinformatics Network

The central focus of the project should be the development
of the H3Africa Bioinformatics Network using established, state-of-the-art
technologies. This section should describe in detail the specific aims,
methods, expected outcomes, metrics for success and quality control, yearly
milestones for each component of the project, and facilities available to
conduct the project. The investigators who will be responsible overall
for the H3Bioinformatics Network and for each sub-project (node) should be identified,
their expertise and experience briefly described and their roles in the
H3Africa Bioinformatics Network outlined.

Description
of subcomponents. In the H3Africa Bioinformatics network, the
applicant is expected to propose other sites of bioinformatics activity that
will constitute the network and work collaboratively with the primary site to
support and facilitate the research of the H3Africa research projects, and to
achieve the other goals of H3Africa. The activities that will take place at
each site must be described well, and the way in which each site will
contribute to the function of the H3Africa Bioinformatics site must be
discussed. The application should also address any plans that the proposed Network
has to enhance some or each of the participating sites so that bioinformatics
capabilities become more wide-spread throughout Africa.

User
support. The H3Africa Bioinformatics Network will be expected
to provide consultation services and technical assistance to the H3Africa
research projects. Applicants should describe their experience in providing
user support, evidence of the quality of that service, and their plans to
implement these service plans for the H3Africa Consortium.

H3Africa
data submission and access. Data generated by H3Africa research
projects must be submitted to international databases according to the data
release policy that the Consortium adopts. Also, genomics data should be
easily accessible by the H3Africa research community. The application
should provide information about the applicant’s experience with, and plans for,
helping researchers both submit and then access genomic data.

Training.
Training activities are a critical component of the H3Africa
Bioinformatics Network. The application must describe a well-considered training
plan and allocate sufficient resources for training both specialists and non-specialists. Training
sites may be at the applicant institution, at other project sites, at an
H3Africa research site, and/or by distance. Examples include
presentations, short courses, or symposia offered independently or in
conjunction with society meetings attended by the user community; web-based
tutorials; and user manuals and training guides.

Access
and Dissemination. Applicants should include a well-described
plan for dissemination of resources to network participants (bioinformatics
"nodes" and H3Africa grantees) as well as a description of how that
community will access resources through the Bioinformatics Network, consistent
with achieving the goals of this program. Any web-based dissemination
activities must emphasize user-centric design.

In the long run, it will be expected that the bioinformatics
network will have a website presence, initially for the H3Africa grantees and
eventually for the public. If appropriate, the web site should provide
information about:

(1) the project’s focus and capabilities, including research
objectives if appropriate;

(2) how to interact with the network and provide feedback;

(3) contact information;

(4) current newsworthy items about the network;

(5) links to online tutorials, if appropriate;

(6) the availability of software, reagents, and other
resources such as FAQs, as applicable; and

(7) links to related NIH-funded resources.

Administration
and management. The organizational and administrative
structure of the project should be described. This section should separately
address organizational structure, including how the PD/PI and the project staff
at both the central site and remote sites will be organized with respect to the
project activities, the administrative and managerial experience of the staff
who will develop and run the resource development activities, and the
distribution of effort across their areas of responsibility. Other issues that
should be discussed in this section include internal decision-making processes,
priority setting mechanisms, administrative aspects of communication among
collaborating components, administrative staff responsibilities, and progress
reporting.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398
Application Guide, with the following modifications:

H3Africa resource and Data sharing plans will be agreed to by the
entire network once all the applications are funded. However, applicants must
provide a plan in the application that must be approved by H3Africa program
staff before the application can be funded, consistent with the goals of the
H3Africa initiative.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide,

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is
received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and for responsiveness by The
National Human Genome Research Institute, NIH. Applications that are incomplete
and/or nonresponsive will not be reviewed.

Applicant Information
Meeting, September 21-22, 2011

The H3Africa staff will host a meeting for applicants to
discuss the NIH Funding Opportunity Announcements (FOAs) regarding H3Africa.
The FOAs call for applications for H3Africa research projects, bioinformatics
networks, collaborative research centers and Biorepository planning grants. The
meeting will be held on the 21st and 22nd of September 2011 at the Windsor Golf
Hotel and Country Club in Nairobi, Kenya.

On the 21st of September staff will discuss each FOA, be
available to answer questions and hold application writing, grants
management and review workshops specific to the NIH application process. On the
evening of the 21st and the day of the 22nd of September NIH staff will be
available to meet with applicants individually with the understanding that the
general questions they ask and answers given by staff will be posted on a
website.

Applicants interested in meeting separately with staff
should schedule an appointment by sending an email to H3Africa_meeting@mail.nih.gov
. A teleconference link will be provided for individuals unable to attend
the first day of the conference. The agenda, information regarding
accommodation and the details of the teleconference can be found here. While
registration for the meeting, except for the teleconference, is not
required please inform H3Africa staff of your intent to attend by sending an
email to H3Africa_meeting@nih.mail.gov
. This will enable NIH to provide you with any updates or additional
logistics about the meeting.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115. Letters of support from institutions may be submitted after the application has been
submitted.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the proposed H3Africa Bioinformatics Network to exert a sustained, powerful influence on the research
field(s) involved, in consideration of the following review criteria and
additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a proposed project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed H3Africa Bioinformatics Network address an important problem or a critical barrier to progress in the field? If the aims
of the proposed H3Africa Bioinformatics Network project are achieved, how will
scientific knowledge, technical capability, and/or clinical practice be
improved? How will successful completion of the aims change the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field? Will the proposed H3Africa Bioinformatics Network further the
goals of the H3Africa Initiative? Will it make a significant difference in
doing genomic-based research in Africa?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the proposed H3Africa Bioinformatics Network project? If Early Stage Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project? Do the PD/PIs have the experience to coordinate a collaborative network of the type proposed?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? Does the application propose creative ways to implement and sustain an H3Africa Bioinformatics Network?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the proposed H3Africa Bioinformatics Network? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?

If the application involves clinical research, are the plans for 1) protection
of human subjects from research risks, and 2) inclusion of minorities and
members of both sexes/genders, as well as the inclusion of children, justified
in terms of the scientific goals and research strategy proposed? Are the plans for interaction, communication and connectivity among the components of the
proposed H3Africa Bioinformatics Network satisfactory? Will they help to
achieve the aims of this FOA? Is the overall management structure sound?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Will the proposed Bioinformatics Network contribute
to the future success of genomics-based and other cutting edge approaches to
research in Africa? Will it contribute significantly to the development of a
useful and productive bioinformatics research community in Africa?

Sustainability

Is the applicant's plan for sustainability feasible?
Will the network and/or its components be well-positioned to apply for
continued funding at the end of the project period?

Do the letters of Institutional and National
commitment suggest that the environment is conducive to a sustained research
enterprise?

Do the collaborations among the network participants
suggest viable partnerships?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please refer
to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National Human Genome Research Institute, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Receive a second level of review by the
appropriate National Advisory Council or Board

Will receive a written critique.

Applications will compete for available funds with all other
recommended applications submitted in response to this FOA. Following initial
peer review, recommended applications will receive a second level of review by
the appropriate National Advisory Council.l The following will be considered in
making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Ability of the proposed project to address the infrastructure
development goals of the H3Africa Initiative

Strength of the Institutional and National commitment to the
project.

Appeals of initial peer
review will not be accepted for applications submitted to this FOA.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume direction,
prime responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with the
awardees for the project as a whole, although specific tasks and activities may
be shared among the awardees and the NIH as defined below. The Terms and
Conditions for the Bioinformatics Network indicate that progress on the project
will be reported to the NIH Division of Program Coordination, Planning, and
Strategic Initiatives (DPCPSI) in the Office of the Director as well as many
Institutes, even though the funds used to support this FOA do not come from all
of the Institutes. These terms apply to the Research Network as a whole, not
just the Bioinformatics Network. The latter will be a member of a larger Research
Network.

Definitions

Steering Committee (SC): The Steering Committee is
the primary governing body of the H3Africa Consortium. PI(s)/PD(s) of each of
the cooperative agreements, and NIH Program Directors serve on the committee.
See further details about the Steering Committee under "Joint
Responsibilities".

Panel of Scientific Consultants (PSC): The PSC will
be composed of four to six senior scientists with relevant expertise who are
not P.I.s of a cooperative agreement involved in the H3Africa Consortium. It will
be responsible for reviewing and evaluating the progress of the H3Africa Consortium.
See more about the PSC below under this topic.

The PD(s)/PI(s) will have the primary responsibility for:

All aspects of the proposed activities, including overall
management of the network, any modification of Network design, conduct of the
study, quality control, data analysis and interpretation, preparation of
publications, and collaboration with other investigators, unless otherwise
provided for in these terms or by action of the Steering Committee.

Awardees agree to the governance of the Consortium through the
Steering Committee and recommendations from the Panel of Scientific
Consultants.

Awardee(s) will agree to accept close coordination, cooperation,
and participation of NIH H3Africa staff in those aspects of scientific and
technical management of the project as described under "NIH Program Staff
Responsibilities."

Awardee(s) will provide goals and reports of progress toward
those goals at regular intervals as requested by H3Africa staff and ensure that
the data produced meet the quality standards agreed to at the beginning of the
project by the H3Africa Consortium;

Awardee(s) will ensure that the data are deposited in the
appropriate public database (e.g., GenBank or other, as specified by H3Africa
program staff), that resources developed as part of this project are made
publicly available according to H3Africa policies, and that results are
published in a timely manner;

Awardee(s) will adhere to the H3Africa policies regarding
intellectual property, data and resource release and other policies that might
be established during the course of this activity that are consistent with
applicable NIH policies, laws, and regulations;

Awardee(s) will retain custody of and have primary rights to the
data and software developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

One H3Africa Project Scientist from each participating Institute
will serve on the Steering Committee and have one vote; the number of NIH votes
may not exceed the number of PI votes on the SC. They and other H3Africa
project team scientists may serve on other study committees, when appropriate.
The H3Africa Project Scientists may work with awardees on issues coming before
the Steering Committee and, as appropriate, other committees, e.g., data
sharing, data release, quality control, core establishment.

The Project Scientists will participate (with the other Steering
Committee members) in the group process of deciding optimal research approaches
and protocol designs, and contributing to the adjustment of research protocols
or approaches as warranted.

The Project Scientists will negotiate goals with the awardees as
necessary, serve as a liaison between the awardees and the Panel of Scientific
Consultants, the
appropriate NIH Institute and Center National Advisory Councils,
the NIH H3Africa Working Group made up of program staff that collectively
manage the program,
and the larger international scientific community, attend all Steering
Committee meetings as voting members and assist in developing operating
guidelines, quality control procedures, and consistent policies for dealing
with recurrent situations that require coordinated action.

The Project Scientists will periodically report progress to the
Director of the Division of Program Coordination, Planning, and Strategic
Initiatives (DPCPSI), of which the Office of Strategic Coordination that
manages the NIH Common Fund is part of as well as OAR, and to the Directors of
NHGRI, FIC, NINDS, and NIDA.

The Office of Strategic Coordination (OSC), NHGRI, NIDA, NINDS
and OAR reserve the right to withhold funding or curtail the study (or an
individual award) in the event of (a) substantive changes in the agreed-upon
work scope with which OSC, NHGRI , NIDA, NINDS and OAR cannot
concur, (b) human subject ethical issues that may dictate a premature
termination.

Support or other involvement of industry or any other third party
in the study -- e.g., participation by the third party; involvement of study
resources or citing the name of the study or NIH support; or special access to
study results, data, findings or resources -- may be advantageous and
appropriate. However, except for licensing of patents or copyrights, support or
involvement of any third party will occur only following notification of and
concurrence by NIH.

Additionally, an agency program official or NIH program director
will be responsible for the normal scientific and programmatic stewardship of
the award and will be named in the award notice. The assigned program
director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Participate in the Steering Committee. A Steering Committee will
serve as the main governing board of the H3Africa Consortium. The
Steering Committee membership will include the NHGRI, NIDA, NINDS Project
Scientist(s) and the P.I. of each awarded cooperative agreement in the H3Africa
Initiative. The Steering Committee Chair will not be an NIH staff member
but will be appointed by H3Africa staff. Additional members may be added by
action of the Steering Committee. Other government staff may attend the Steering
Committee meetings, if their expertise is required for specific discussions.
Because the Consortium will include investigators funded by this FOA and other
FOA's for H3Africa, it is possible that H3Africa staff will create appropriate
subcommittees to handle interests that may be specific to a set of awardees
under a specific FOA.

The Steering Committee
will:

Discuss progress in meeting the goals of the several H3Africa Consortium
member projects;

Develop recommendations for uniform procedures and policies
necessary to meet the goals of the Consortium, for example for data quality
measures and assessment, conventions for data deposition;

Schedule the time for, and prepare concise (3 to 4 pages)
summaries of, the Steering Committee meetings, which will be delivered to
members of the group within 30 days after each meeting. The SC will meet twice
a year with intermittent conference calls.

Each full member (limited to one person per awarded center, in
the case of multiple PI’s per center) will have one vote.

Awardee members of the Steering Committee will be required to
accept and implement policies approved by the Steering Committee.

The Panel of Scientific Consultants (PSC). The PSC will
provide recommendations to the Directors of the DPCPSI, NHGRI, FIC, NIDA, NINDS
about continued support of each of the components of the H3Africa Consortium.

The PSC will meet at least once a year. During part of this
meeting, there will be a joint meeting with the Steering Committee to allow the
PSC members to interact directly with the awardees.

Annually, the PSCs will make recommendations regarding progress
of the H3Africa Consortium and present recommendations regarding changes, if
any, that may be necessary in the H3Africa Consortium program to the Directors
of the DPCPSI, NHGRI, FIC, NIDA and NINDS.

Dispute Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. The three members will be: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.